Retatrutide Phase 3 Results: Every TRIUMPH and TRANSCEND Trial by Dose
Retatrutide phase 3 results from all 6 trials so far, dose by dose: weight loss, A1C, side effects, the Ozempic head-to-head and what's still unreported.
On this page
- Retatrutide Phase 3 results by dose
- Retatrutide vs Ozempic in the first head-to-head trial
- Why Lilly reports two sets of numbers
- How many people lost a quarter of their weight?
- Blood sugar and heart results
- Sleep apnea and knee pain results
- Side effects and dropouts across the six trials
- What's still unreported, as of October 2026
As of October 2026, the retatrutide phase 3 results cover six trials, and the drug beat placebo in five of them and Ozempic 2 mg in the sixth. On the top 12 mg dose, average weight loss ran from 16.8% over 40 weeks in people with type 2 diabetes (TRANSCEND-T2D-1) to 28.7% over 68 weeks in people with knee osteoarthritis (TRIUMPH-4), against 2.1% to 4.0% on placebo. The main obesity trial, TRIUMPH-1, came in at 28.3% over 80 weeks, and in the first head-to-head, TRANSCEND-T2D-2, 12 mg took off 20.9% against 9.4% on Ozempic. Depending on the trial, 5.1% to 18.2% of people on 12 mg stopped because of side effects.
Key takeaways
- In TRANSCEND-T2D-2, people with type 2 diabetes lost 20.9% of their weight on 12 mg against 9.4% on Ozempic 2 mg, the highest approved dose.
- Going from 9 mg to 12 mg added between 1.0 and 2.4 points of weight loss across the six trials, and in five of them more people quit because of side effects.
- Two versions of the weight results are public for four of the trials, and the gap between them reached 6.4 points in TRIUMPH-4.
- People with type 2 diabetes lost less weight at every dose, but their A1C fell by up to 2.2 points.
- As of October 2026, three of the six trials have a journal paper, none has posted results on ClinicalTrials.gov, and the tirzepatide head-to-head hasn't reported.
The numbers below come from Lilly's trial releases and the four journal papers so far, in the New England Journal of Medicine (NEJM) and The Lancet. Unless a line says otherwise, they're Lilly's "efficacy estimand", which describes people who stayed on the drug as assigned. The retatrutide clinical trials hub maps the trials that haven't reported yet.
Retatrutide Phase 3 results by dose
Together the six trials randomized 7,720 people, adding up Lilly's figures for each trial. TRIUMPH-3, TRIUMPH-4 and TRANSCEND-T2D-2 skipped the 4 mg arm, and TRANSCEND-T2D-2 used Ozempic 2 mg instead of placebo. The last column is our subtraction. Against placebo, it's the part of the weight loss the drug itself accounts for; against Ozempic, it's how far retatrutide pulled ahead.
| Trial (people) | Who took part | Weeks | Start weight | 4 mg | 9 mg | 12 mg | Comparator | 12 mg minus comparator |
|---|---|---|---|---|---|---|---|---|
| TRIUMPH-1 (2,339) | Obesity, no diabetes | 80 | 248.5 lb | 19.0% | 25.9% | 28.3% | 2.2% (placebo) | 26.1 points |
| TRIUMPH-2 (1,152) | Obesity with type 2 diabetes | 80 | 234.6 lb | 12.7% | 19.1% | 20.8% | 4.0% (placebo) | 16.8 points |
| TRIUMPH-3 (1,949) | BMI 35+ with heart disease | 80 | 245.6 lb | not tested | 21.6% | 22.6% | 3.2% (placebo) | 19.4 points |
| TRIUMPH-4 (445) | Knee osteoarthritis | 68 | 248.5 lb | not tested | 26.4% | 28.7% | 2.1% (placebo) | 26.6 points |
| TRANSCEND-T2D-1 (537) | Type 2 diabetes, diet alone | 40 | 213.6 lb | 11.5% | 15.5% | 16.8% | 2.5% (placebo) | 14.3 points |
| TRANSCEND-T2D-2 (1,298) | Type 2 diabetes on metformin | 80 | 225.8 lb | not tested | 19.5% | 20.9% | 9.4% (Ozempic 2 mg) | 11.5 points |
In pounds, 12 mg meant an average of 70.3 lb in TRIUMPH-1 and 71.2 lb in TRIUMPH-4. The three type 2 diabetes trials sit lowest, and TRANSCEND-T2D-1 ran only 40 weeks; Lilly said weight hadn't plateaued by then.
The dose curve flattens at the top. In TRIUMPH-1, going from 4 mg to 9 mg added 6.9 points; going from 9 mg to 12 mg added 2.4. The retatrutide weight loss results page covers how fast the weight comes off and what an average hides.
Retatrutide vs Ozempic in the first head-to-head trial
TRANSCEND-T2D-2 is the first Phase 3 trial to put retatrutide against another incretin drug; Lilly released the topline on October 28, 2026. It randomized 1,298 adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor, to retatrutide 9 mg, 12 mg or Ozempic 2 mg, the highest approved dose, for 80 weeks. It was open-label, so people knew which drug they were on.
Retatrutide vs Ozempic in TRANSCEND-T2D-2
1,298 adults with type 2 diabetes on metformin, 80 weeks, open-label, efficacy estimand
Both doses cut A1C further than Ozempic from 8.3%, and both more than doubled its weight loss: 47.4 lb on 12 mg against 20.9 lb. Stomach effects were much closer, and constipation was less common on 12 mg (13.1% against 19.8%).
Two limits. Every figure is the efficacy estimand, with no everyone-randomized numbers and no paper yet. And the 9 mg A1C win is "nominal", outside the trial's controlled testing plan; the 12 mg comparisons were inside it. The retatrutide vs Ozempic page covers what this means if you're on Ozempic now.
Why Lilly reports two sets of numbers
Lilly uses two yardsticks: an efficacy estimand (as if everyone had stayed on the drug without other weight treatments) and a treatment-regimen estimand (everyone randomized, whether they kept taking it or not). The NEJM and Lancet obesity papers lead with the second, so TRIUMPH-1's NEJM headline is 25.0% on 12 mg, not 28.3%. Both are public for four trials; each cell reads efficacy / treatment-regimen.
| Trial | 9 mg | 12 mg | Placebo |
|---|---|---|---|
| TRIUMPH-1 | 25.9% / 23.7% | 28.3% / 25.0% | 2.2% / 3.9% |
| TRIUMPH-2 (The Lancet) | 19.1% / 16.8% | 20.8% / 18.8% | 4.0% / 5.1% |
| TRIUMPH-4 | 26.4% / 20.0% | 28.7% / 23.7% | 2.1% / 4.6% |
| TRANSCEND-T2D-1 | 15.5% / 13.9% | 16.8% / 15.3% | 2.5% / 2.6% |
The widest gap is 6.4 points, on 9 mg in TRIUMPH-4, where the most people quit. Placebo moves the other way, likely because that count keeps people who started other weight treatments. TRIUMPH-3 and TRANSCEND-T2D-2 have efficacy numbers only.
Our read: the treatment-regimen figure is the better guess at what a group of real people gets, dropouts included. For 12 mg in TRIUMPH-1 that's 25.0%, still a quarter of starting weight lost for the average person.
How many people lost a quarter of their weight?
In TRIUMPH-1, 62.5% of people on 12 mg lost at least 25% of their body weight over 80 weeks, about 5 in 8, against 2.2% on placebo. On 9 mg it was 52.9%, and on 4 mg 27.8%. Losses of 35% or more happened in 27.2% of people on 12 mg, a little over 1 in 4.
By week 80, 65.3% of people on 12 mg had a BMI under 30, about 2 in 3, and 33.3% were under 25. Waists shrank 24.1 cm (9.5 in) from 118.3 cm; see retatrutide belly fat results.
TRIUMPH-4 landed close at 58.6%, and TRIUMPH-2, with type 2 diabetes, at 34.9%. TRIUMPH-4's knee pain results, a fall of 4.5 points on 9 mg on Lilly's 0 to 10 scale, have their own page at TRIUMPH-4.
What the 104-week extension showed
TRIUMPH-1 kept 532 people going to week 104, all with a starting BMI of 35 or more who had finished 80 weeks on the drug without stopping or cutting their dose. Everyone, the placebo group included, spent 24 more weeks on retatrutide at the highest dose they could tolerate, 9 or 12 mg.
By week 104, people who started on 12 mg were down 30.3% (85.0 lb) from 268.3 lb, or 29.9% on the treatment-regimen count. Former placebo takers were down 19.2%. Lilly's release gives no side effect numbers for the extension, and since it only took people who had done well, read 30.3% as a best case.
Blood sugar and heart results
Three trials reported A1C, the 3-month blood sugar average. In TRANSCEND-T2D-1, from 7.9%, A1C fell 1.7 points on 4 mg, 2.0 on 9 mg and 1.9 on 12 mg over 40 weeks, against 0.8 on placebo; its Lancet paper reported no severe hypoglycemia. In TRIUMPH-2, from 7.7%, it fell 1.4, 1.6 and 1.5 points against 0.2, and 79.0% of people on 12 mg reached 6.5% or below, against 26.3% on placebo. TRANSCEND-T2D-2 showed the biggest drops, 2.2 points on both doses from 8.3%. So 12 mg did no better than 9 mg on A1C in any of the three.
Heart risk markers improved in every trial that reported them.
| Trial (highest dose) | Triglycerides | Non-HDL cholesterol | Systolic blood pressure | hsCRP |
|---|---|---|---|---|
| TRIUMPH-1 (up to) | -41.0% | -24.2% | -12.3 mmHg | fell, no number given |
| TRIUMPH-2 | -39.5% | -19.6% | -10.8 mmHg | -58.3% |
| TRIUMPH-3 | -37.0% | -16.5% | -9.3 mmHg | -51.2% |
| TRIUMPH-4 | fell, no number given | fell, no number given | -14.0 mmHg | fell, no number given |
| TRANSCEND-T2D-1 (up to) | -39.6% | -19.8% | -6.4 mmHg | not reported |
In TRANSCEND-T2D-2, Lilly says the first three measures improved more than on Ozempic, but gave no numbers.
TRIUMPH-3 is the only trial with heart event counts, and events were rarer than Lilly expected. The 5-part measure (MACE-5) was 44 events on retatrutide against 52 on placebo, hazard ratio 0.82 (95% CI 0.55 to 1.22); the 3-part measure was 27 against 23, hazard ratio 1.12 (0.64 to 1.96). Both intervals cross 1, so neither shows benefit or harm. TRIUMPH-Outcomes, about 10,000 people, is built to answer that, with primary completion estimated for February 2029.
Sleep apnea and knee pain results
TRIUMPH-1 and TRIUMPH-2 carried "basket" substudies, and the NEJM papers give per-dose results with placebo. Sleep apnea is scored in breathing pauses per hour of sleep (AHI), and the TRIUMPH-1 group started at 58.6. These use NEJM's hybrid-treatment estimand, so they run below Lilly's efficacy-estimand "up to 36.1 events per hour (60.6%)".
| Substudy (people) | Measure | 4 mg | 9 mg | 12 mg | Placebo |
|---|---|---|---|---|---|
| TRIUMPH-1 knee osteoarthritis (574) | WOMAC pain score, points | -3.2 | -3.5 | -3.6 | -1.9 |
| TRIUMPH-1-OSA, no diabetes (243) | AHI, events per hour | -22.9 | -34.3 | -31.7 | -9.9 |
| TRIUMPH-2-OSA, type 2 diabetes (448) | AHI, events per hour | -19.2 | -24.7 | -25.4 | -10.3 |
In TRIUMPH-1's sleep group, 9 mg did a little better than 12 mg. People with diabetes improved less, and they also lost less weight: up to 18.5% in TRIUMPH-2-OSA against 22.2% in TRIUMPH-1-OSA, counting everyone randomized.
Side effects and dropouts across the six trials
Stomach effects led in every trial, and the TRANSCEND-T2D-1 release says they came mainly while the dose was going up. All six trials used the same schedule: start at 2 mg, then step up every 4 weeks. The table shows how often each effect showed up at least once, with placebo (Ozempic 2 mg in TRANSCEND-T2D-2) in parentheses.
| Trial | Nausea, 12 mg | Diarrhea, 12 mg | Vomiting, 12 mg | Burning or sensitive skin (dysesthesia), 12 mg | Stopped due to side effects, 12 mg | Stopped, 9 mg |
|---|---|---|---|---|---|---|
| TRIUMPH-1 | 42.4% (14.8%) | 32.0% (13.5%) | 25.3% (4.8%) | 12.5% (0.9%) | 11.3% (4.9%) | 6.9% |
| TRIUMPH-2 | 28.0% (8.0%) | 33.6% (13.2%) | 15.7% (4.2%) | 7.3% (0.7%) | 7.7% (4.9%) | 11.6% |
| TRIUMPH-3 | 22.4% (5.8%) | 24.4% (8.7%) | not reported | 6.4% (1.3%) | 13.5% (4.8%) | 9.8% |
| TRIUMPH-4 | 43.2% (10.7%) | 33.1% (13.4%) | 20.9% (0.0%) | 20.9% (0.7%) | 18.2% (4.0%) | 12.2% |
| TRANSCEND-T2D-1 | 26.5% (3.7%) | 22.8% (4.5%) | 17.6% (2.2%) | 4.4% (0.0%) | 5.1% (0.0%) | 4.5% |
| TRANSCEND-T2D-2 | 23.8% (21.3%) | 32.7% (26.4%) | 15.0% (13.2%) | 6.5% (2.7%) | 7.9% (2.7%) | 4.8% |
Nausea on 12 mg in TRIUMPH-1 hit about 4 in 10 people; against Ozempic it came out close to even. Lilly says most dysesthesia, a burning or oversensitive feeling in the skin, was mild to moderate and cleared up on treatment. TRIUMPH-4 had the highest dropout, nearly 1 in 5 on 12 mg, and Lilly tied it to starting BMI, with some people quitting because they felt they were losing too much weight.
Against the dose table, moving from 9 mg to 12 mg added between 1.0 point (TRIUMPH-3) and 2.4 points (TRIUMPH-1) of weight loss, and more people quit on 12 mg in every trial except TRIUMPH-2. Lilly's release doesn't say why TRIUMPH-2 went the other way.
Our read: in every trial, the average loss on 9 mg was at least 91% of the loss on 12 mg, and in five of the six fewer people quit on 9 mg. If retatrutide is ever prescribed, that's a trade-off to raise with your doctor.
Lilly's releases give no serious adverse event rate, and neither does the TRIUMPH-1 NEJM abstract. The TRIUMPH-2 Lancet paper counts 6 deaths across the three retatrutide doses and 1 on placebo, all judged unrelated to the drug. Retatrutide nausea covers how long the sickness lasts, and retatrutide Phase 2 shows how the earlier trials compared.
What's still unreported, as of October 2026
- A Europe PMC title search through October 31, 2026 found no paper yet for TRIUMPH-3, TRIUMPH-4 or TRANSCEND-T2D-2, and none of the six has posted results on ClinicalTrials.gov, where per-arm serious event tables usually appear.
- Full TRANSCEND-T2D-2 results will come at a medical meeting and in a journal, Lilly says, with no dates. About 650 people carry on for 24 more weeks, to February 2027 (estimated).
- TRIUMPH-5 puts about 800 adults with obesity on retatrutide or tirzepatide for 80 weeks. Primary completion is November 2026 (estimated), with no result by October 31; retatrutide vs tirzepatide lines up what's known.
- TRANSCEND-T2D-3, about 320 people with type 2 diabetes and moderate or severe kidney impairment, had an estimated primary completion of October 2026 and no topline as of October 31.
Retatrutide's road to approval
The results so far and what comes next, as of October 2026
Lilly last said, on September 29, 2026, that it plans to submit retatrutide to the FDA in the first quarter of 2027 as a Biologics License Application (BLA). On October 2, 2026, the FDA decided that retatrutide is a drug, not a biological product, so an application would need to be filed under section 505 of the Federal Food, Drug, and Cosmetic Act. Lilly's appeal on that question is pending in the Seventh Circuit, and we found no ruling as of October 31, 2026. The FDA approval page tracks that fight, and retatrutide release date follows the steps after a filing.
Every result here came from Lilly's own retatrutide, given in a supervised trial. Products listed online as retatrutide for sale aren't Lilly's, and some aren't retatrutide at all: in September 2026, Australia's TGA tested one after a serious adverse event report and found only undeclared semaglutide, at about 8 times the level in approved products.
Frequently asked questions
What were the results of the retatrutide phase 3 trial?
Six Phase 3 trials have reported as of October 2026, and retatrutide beat placebo in five of them and Ozempic 2 mg in the sixth. In TRIUMPH-1, the main obesity trial, people on 12 mg lost 28.3% of their body weight on average over 80 weeks, against 2.2% on placebo (Lilly's efficacy estimand). Nausea, diarrhea, vomiting and constipation were the most common side effects, and 5.1% to 18.2% of people on 12 mg stopped because of side effects, depending on the trial.
What did TRIUMPH-1 show?
TRIUMPH-1 randomized 2,339 adults with obesity, or overweight with a weight-related condition, and no diabetes, to 4, 9 or 12 mg or placebo for 80 weeks. The New England Journal of Medicine published it on September 29, 2026: counting everyone randomized, 12 mg cut weight by 25.0% against 3.9% on placebo, while Lilly's efficacy estimand gives 28.3% against 2.2%. In a 104-week extension of 532 people who had finished 80 weeks on the drug, those who started on 12 mg were down 30.3% on Lilly's efficacy estimand.
What did TRIUMPH-2 show?
TRIUMPH-2 tested retatrutide in 1,152 adults with obesity or overweight and type 2 diabetes for 80 weeks. Average weight loss on 12 mg was 20.8% against 4.0% on placebo on Lilly's efficacy estimand, or 18.8% against 5.1% counting everyone randomized, as The Lancet reported on September 29, 2026. A1C fell by up to 1.6 points from a starting level of 7.7%, and its sleep apnea substudy of 448 people was published in NEJM on October 21, 2026.
What did TRIUMPH-3 show?
TRIUMPH-3 enrolled 1,949 adults with a BMI of 35 or more and established heart or blood vessel disease. After 80 weeks, people on 12 mg had lost 22.6% of their weight against 3.2% on placebo, and hsCRP, a marker of inflammation, fell 51.2% on the highest dose. Heart events were rarer than expected, and the counts showed no clear difference either way.
Did any Phase 3 trial compare retatrutide with another drug?
Yes, one so far. In TRANSCEND-T2D-2, reported October 28, 2026, people with type 2 diabetes lost 20.9% of their weight on 12 mg against 9.4% on Ozempic 2 mg over 80 weeks, and A1C fell 2.2 points against 1.8. The tirzepatide comparison, TRIUMPH-5, has an estimated primary completion of November 2026 on ClinicalTrials.gov and hadn't reported as of October 31, 2026.
When will retatrutide be approved after these Phase 3 results?
No approval date exists, and no approved version exists yet anywhere. Lilly last said, on September 29, 2026, that it plans to submit retatrutide to the FDA in the first quarter of 2027 as a Biologics License Application (BLA). On October 2, 2026, the FDA decided that retatrutide is a drug, not a biological product, so an application would need to be filed under section 505 of the Federal Food, Drug, and Cosmetic Act. Lilly's appeal on that question is pending in the Seventh Circuit, and we found no ruling as of October 31, 2026.
Sources
- Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1 topline). Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial (TRIUMPH-4 topline). Eli Lilly and Company (PR Newswire), 2025. prnewswire.com
- Lilly's triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes (TRANSCEND-T2D-1 topline). Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial (TRANSCEND-T2D-2 topline). Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- What to know about retatrutide (Lilly FAQ, last updated October 2026). Eli Lilly and Company, 2026. lilly.com
- Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (Jastreboff AM et al., TRIUMPH-1). New England Journal of Medicine, 2026. doi.org
- Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C (TRIUMPH-2 and TRIUMPH-3 topline). Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- Bellido V et al., TRIUMPH-2: retatrutide in adults with obesity or overweight and type 2 diabetes, Lancet 2026;408(10563):1455-1472. The Lancet, 2026. doi.org
- Lilly's triple agonist, retatrutide, delivered substantial weight loss and A1C reduction, underscoring its potential promise for people with obesity and type 2 diabetes. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. The Lancet, 2026. doi.org
- Lilly's triple agonist, retatrutide, drove substantial improvements in weight, A1C, knee osteoarthritis pain and obstructive sleep apnea (ADA 2026 presentations). Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
- TRIUMPH-Outcomes: retatrutide and cardiovascular and kidney outcomes (NCT06383390). ClinicalTrials.gov, 2026. clinicaltrials.gov
- Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea (Grunstein RR et al., TRIUMPH-1-OSA and TRIUMPH-2-OSA). New England Journal of Medicine, 2026. doi.org
- Europe PMC search: journal articles with retatrutide or LY3437943 in the title, June 2026 onward. Europe PMC, 2026. ebi.ac.uk
- ClinicalTrials.gov API: studies with retatrutide as an intervention. U.S. National Library of Medicine, 2026. clinicaltrials.gov
- Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2, NCT06260722). ClinicalTrials.gov, 2026. clinicaltrials.gov
- A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5, NCT06662383). ClinicalTrials.gov, 2026. clinicaltrials.gov
- TRANSCEND-T2D-3: retatrutide vs placebo in type 2 diabetes with moderate or severe renal impairment (NCT06297603). ClinicalTrials.gov, 2026. clinicaltrials.gov
- FDA letter of October 2, 2026 on retatrutide's regulatory status, filed as Doc. 46-2 in Eli Lilly and Company v. Kennedy, 7th Cir. No. 26-1301. U.S. Food and Drug Administration (via CourtListener), 2026. storage.courtlistener.com
- Eli Lilly and Company v. Robert Kennedy Jr., 7th Cir. No. 26-1301 (docket). CourtListener, 2026. courtlistener.com
- TGA tests counterfeit retatrutide product following serious adverse event report. Therapeutic Goods Administration, 2026. tga.gov.au
Dr. Juan Pablo Frías, MD
Physician-Scientist & Clinical Trialist • Endocrinology, Diabetes & Metabolism
Dr. Frías earned his M.D. from Vanderbilt University School of Medicine and completed his endocrinology fellowship at UC San Diego. A principal investigator on landmark incretin trials (including retatrutide, tirzepatide and semaglutide), he reviews all guides on Retatrutide360 for clinical accuracy, dosing safety and evidence fidelity.
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Retatrutide Clinical Trials
Retatrutide clinical trials as of October 2026: all 6 Phase 3 results, including the first head-to-head with Ozempic, what's still running and who can join.
Retatrutide Weight Loss Results
Retatrutide weight loss averaged up to 28.3% in TRIUMPH-1, and 20.9% vs 9.4% on Ozempic head to head. Every trial by dose, who lost less, what averages hide.
Is Retatrutide FDA Approved? Approval Status and Timeline
Is retatrutide FDA approved? No. Lilly plans to file in Q1 2027, and the FDA says it must go in as a drug. See the review clock and legal ways to get it now.
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